Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

ENDO GIA Stapler With Duet Tissue Reinforcement System (TRS) Used in Pulmonary Resections

Lead Sponsor:

Medtronic - MITG

Conditions:

Lung Disease

Eligibility:

All Genders

20-79 years

Phase:

NA

Brief Summary

The objective of this study is to confirm superiority between a test treatment group using Endo GIA stapler with Duet Tissue Reinforcement System (TRS) and a current international standard of care gro...

Detailed Description

Air leak is a complication of pulmonary surgical procedures that include pulmonary lobectomy, segmentectomy, and bullectomy, reported to occur in 33% to 75% of cases. Prolonged air leak continuing fo...

Eligibility Criteria

Inclusion

  • The patient is between 20-79 years of age.
  • The patient is eligible to be given pulmonary Lobectomy.
  • The patient is scheduled to undergo pulmonary Lobectomy.
  • Performance status 0\~1 (Eastern Cooperative Oncology Group classification).
  • The patient has no history of lung surgery.
  • The patient is healthy organ function.
  • The patient is scheduled for surgery with staplers .
  • The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion

  • The patient has suffered thoracic trauma or has previously undergone pneumonectomy surgery.
  • The patient has an active bacterial infection or fungal infection.
  • The patient is undergoing continuing systemic administration (intravenous or oral) of steroids.
  • The patient condition is complicated by uncontrolled diabetes mellitus.
  • The patient participation is judged difficult due to study complications related to a psychiatric disorder or psychological symptoms.
  • The patient undergoes surgical procedure other than lobectomy during surgery.
  • Reinforcement material other than the study materials are applied during surgery.
  • The patient judged unsuitable for study participation by the investigator for any other reason.

Key Trial Info

Start Date :

August 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2012

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT01241617

Start Date

August 1 2010

End Date

January 1 2012

Last Update

January 24 2012

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Junendo University School of Medicine

Tokyo, Japan